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Comparison of Two Pain-treatment Techniques After Cesarean Section

M

Michał Borys

Status and phase

Completed
Phase 4

Conditions

Cesarean Section
Neuropathic Pain
Pain Management

Treatments

Drug: Bupivacaine
Drug: Metamizol
Drug: Paracetamol
Procedure: QL (quadratus lumborum block)
Drug: Morphine
Procedure: TAP (transversus abdominis plane block)
Device: Needle
Drug: Ketoprofen

Study type

Interventional

Funder types

Other

Identifiers

NCT02804126
KE-0254/85/2016

Details and patient eligibility

About

Comparison of two types of analgesia after cesarean section.

All patients will anaesthetised with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). 1, 2, 6 months after surgery each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).

Full description

Written consent will be obtained before the cesarean section. Only subarachnoidally anaesthetised patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.

At the end of surgery ultrasound-guided regional block will be performed. Each patient will be randomly allocated to one of the treated group: transversus abdominis plane block (TAP) or quadratus lumborum (QL). Patients receive 0.2 mL of local anesthetic solution (0.25 % bupivacaine) on each side.

Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours after the end of operation.

Paracetamol, metamizol, ketoprofen may be given as required. Whenever pain exceeds 40 (VAS) 5 mg of morphine will be given intravenously (maximum two dosages per day).

1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.

Enrollment

232 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • obtained consent
  • singleton pregnancy
  • subarachnoid anaesthesia

Exclusion criteria

  • coagulopathy
  • allergy to to local anesthetics
  • depression, antidepressant drugs treatment
  • epilepsy
  • usage of painkiller before surgery
  • addiction to alcohol or recreational drugs

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

232 participants in 2 patient groups

TAP (transversus abdominis plane)
Experimental group
Description:
Ultrasound-guided transversus abdominis plane block at the end of cesarean section
Treatment:
Drug: Metamizol
Drug: Paracetamol
Drug: Ketoprofen
Device: Needle
Drug: Morphine
Drug: Bupivacaine
Procedure: TAP (transversus abdominis plane block)
QL (quadratus lumborum)
Experimental group
Description:
Ultrasound-guided quadratus lumborum block at the end of cesarean section
Treatment:
Drug: Metamizol
Drug: Paracetamol
Drug: Ketoprofen
Device: Needle
Procedure: QL (quadratus lumborum block)
Drug: Morphine
Drug: Bupivacaine

Trial contacts and locations

1

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Central trial contact

Michal Borys, MD, PhD

Data sourced from clinicaltrials.gov

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